Universal disposable cartridge for parenteral administration of drugs



W. F. ELIAS April 30, 1968 UNIVERSAL DISPOSABLE CARTRIDGE FOR PARENTERAL ADMINISTRATION OF DRUGS Filed Dec. 1, 1964 I I I am wm w B 8 NW QN 8 1||L f llllllllllll [IF lllllll ll l I. A N J 1 I l i l l I l l l I lll-llllll|l|l I I 9 mm 0 w 9 Q m mm 2 E v INVENTOR WILLIAM FELIAS AT TOR N EY United States Patent 3,380,452 UNIVERSAL DESPOSABLE CARTRIDGE FOR PAR- ENTERAL ADMINISTRATION OF DRUGS William F. Elias, West Chester, Pa, assignor to American Home Products Corporation, New York, N.Y., a corporation of Delaware Filed Dec. 1, 1964, Ser. No. 415,005 2 Claims. (Cl. 128221) ABSTRACT OF THE DISCLOSURE A disposable cartridge for parenteral administration of drugs wherein the cartridge comprises a unitary body of plastic material having molded therein, structures adapting said cartridge for attachment thereto any of (l) a sterile cap; (2) a luer type needle; (3) a permanently attached cannular; (4) a removable needle guard; as well as (5) for use as or with a hypodermic syringe which may have a screw-thread or an abutment for maintaining the cartridge in the syringe.

This invention relates generally to devices useful for administering drugs by the parenteral route. More particularly, the invention pertains to a novel universal disposable cartridge adaptable for use as or with a hypodermic syringe.

Of the many kinds of hypodermic syringe assemblies obtainable commercially, those of the type referred to as cartridge-syringe units have become widely accepted and used by the medical profession. The cartridge-syringe unit generally comprises a transparent cartridge containing an injectable material, a hypodermic needle permanently affixed to one end of the cartridge, and, in the other end thereof, a reciprocal plunger, to which is attachable a push rod, whereby the injectable material may be forced out of the cartridge and through the needle. Such units, described and claimed in U.S.P. 2,671,449 and U.S.P. 2,671,450, for example, are available under the Tubex registered trademark.

The use of glass for the transparent cartridge syringe units of the above type has been conventional in most applications due primarily to its optimum transparency, susceptibility to cleaning and sterilization, and its inertness to the medicaments contained in the cartridges. It has similarly been conventional that the hypodermic needle be stainless steel of a grade and composition which is impervious to known medicaments.

Up to the present time, these known cartridge-syringe u F un1ts comprising a glass amp-ule and a metal hypodermic needle, have usually had these two elements affixed to each other by the crimping of a metal ferrule having the needle or cannula afiixed thereto, to the end of the glass tube or ampule contoured or beaded for that purpose. While this general arrangement is the one in widest use for these cartridge-syringe units, there are known drawbacks inherent in this mode of assembly. For example, such assemblies require very close control of the dimensions of the glass tube with respect to the contoured or beaded end to which the metal ferrule is to be crimped. This in itself is very costly. The assemblies also require the machining of the metal ferrules to micro-tolerances. This adds further to the cost of manufacture. Moreover, the metal ferrules must be sealed with rubber gaskets, diaphragms, washers, or the like to render the units fluidtight. Another drawback inherent in these assemblies is that slight variations in the separate piece to piece components, when handled in extremely large quantities, creates great inspection problems. As a result, failure to detect and eliminate off-size pieces results in a high perccntage of breakage of the glass ampules, loss of ferrules, loss of cannulae, loss of medicaments, and loss due to work stoppage.

In certain attempts to eliminate the recognized disadvantages of the mode of assembling cartridge-syringe units as referred to above, the ampules have been made entirely of synthetic plastics with a hypodermic needle of metal permanently affixed thereto without the use of a metal ferrule. However, the various cartridge-syringe units of such materials known previously have been seriously limited in their respective use to only a restricted number of medicaments which the particular plastic material will not contaminate. Moreover, they have been further restricted in use in that they have had to have the hypodermic needles permanently aflixed at the factory. Further, in attempts to avoid the necessity of a metal ferrule to aifix the hypodermic needle to the ampule, the units have been so constructed as to be cumbersome, unwieldy and even unsterile.

In consideration of the foregoing, it is a primary object of the present invention to provide a cartridge-syringe assembly of reduced cost comprising a unitary plastic body adapted for universal use.

It is another object of the invention to provide such a cartridge-syringe assembly provided with a nose structure wherein an adhesive may be employed at the factory to attach a metal hypodermic needle thereto without the need of a metal or other ferrule.

Another object of the invention is to provide such a cartridge-syringe assembly wherein the nose structure thereof adapts it for use with a standard luer type needle as desired by the user when a needle is not permanently affixed to the unit at the factory.

Yet another object of the invention is to provide such a ca1tridge-syringe assembly wherein the nose structure thereof is also adapted to fit conventional stopcock arrangernents currently used, for example, by anestheologists for the introduction of drugs into a patient through an indwelling catheter.

Another object is to provide a plastic cartridge-syringe unit wherein the bore in the nose structure is particularly adapted to have locked therein a charge of resinous adhesive material which may have an affinity for the metal hypodermic needle to be affixed permanently to the unit, but not necessarily for the plastic material of which the unit is formed.

It is another object to provide a plastic cartridge unit assembly of a novel structure particularly adapted for use with a metal or plastic cartridge holder.

Another object is to provide such a cartridge unit assembly wherein the plastic material employed presents a minimum problem of toxicity to the medicaments to be contained in the units.

Another object of the invention is to provide a uni-- versally usable, disposable, unitary cartridge-syringe body unit which lends itself to mass production methods of production.

It is another object of the invention to provide such a cartridgesyringe unit with a cap adapted for removably sealing the nose end of the unit in sterile condition when the unit is not provided with a permanently affixed hypodermic needle at the factory.

Other objects and advantages of the invention will appear from an understanding of the invention upon reading the description thereof which follows.

Generally, the novel cartridge-syringe unit of the invention comprises a unitary, generally cylindrical hollow body of plastic material, said body having at one end thereof an integral reduced axially extending nose portion, said reduced nose portion having a first proximate region having a first predetermined diameter adapted to fit into a cartridge holder, a second region distally of said first region and having a second predetermined diameter less than said first diameter and adapted to have affixed thereto the mounting means of a standard luer type needle, a third region distally of said second region, said third region having a third predetermined diameter less than said second diameter and adapted to receive the end of a flexible cannula cover thereon, and a bore extending through said integral reduced nose portion axially thereof and opening at its proximal end into said hollow body and at its distal end out of said third region. Preferably, said first proximate region has means thereon for fixing said unit in a cartridge holder against axial movement therein and, in a most preferred form of said means, the latter comprise a screw-thread raised on the circumferential surface of said first region. Also, preferably, said second region has said second predetermined diameter thereof tapering inwardly in the distal direction for a reason that will appear hereinafter. Advantageously, said bore has a first proximate portion thereof having a first predetermined smaller diameter and a second distal portion thereof in communication with said first proximate portion and having a larger predetermined larger diameter whereby said bore is adapted to receive a hypodermic needle in said distal portion only, with the cannula of the needle in communication with said proximate portion of said bore. Preferably, said distal portion of said bore has, at the extreme distal end thereof, a third portion thereof having a third predetermined largest diameter adapted to receive an adhesive material, whereby a hypodermic needle positioned in said second distal portion as aforesaid may be permanently aifixed to said body. Advantageously, the third bore portion has on its internal surface thereof an annular bead which functions as locking means for the adhesive material which may not have an affinity for the particular plastic material of which the unit is formed.

In one embodiment of the invention, where it is desired to furnish the novel cartridge-syringe unit without a hypodermic needle permanently affixed thereto, the unit, whether empty and sterile or prefilled with a therapeutic preparation, is provided with a cap of novel design over the nose end of the body. The cap comprises a generally cup-shaped body having a predetermined internal diameter substantially equal to the external diameter of said second region and tapering inwardly in the direction from the open end of said cup-shaped body to the closed end thereof, whereby said cap is adapted to be mounted on said body with a friction fit between said internal diameter of said cup and said diameter of said second region of said neck portion. Integral with the interior of the closed end of said cup is a plug member having the proximate portion thereof dimensioned to fit within said largest distal portion of said bore of said body as diminished by said annular bead thereon, and a distal portion dimensioned to fit within said second portion of said bore.

Preferred embodiments of the invention, with respect to the novel cartridge-syringe unit and adjunctive structures are now described below and illustrated in the accompanying drawings. As will be understood, the description and drawings are intended to be illustrative only and not to limit the scope of the invention as defined in the appended claims.

Reference is now made to the drawings wherein:

FIG. 1 is a side elevational view of a cartridge-syringe unit per se in accordance with the present invention;

FIG. 2 is a side elevational view of a cover suitable for use with the cartridge-syringe unit of FIG. 1, when, as shown in the latter figure, the unit is not equipped with an atfixed hypodermic needle;

FIG. 3 is a cross-sectional view of the unit of FIG. 1 taken on line 33 of the latter, with the cap of FIG. 2 being shown in phantom mounted thereon;

FIG. 4 is a cross-sectional view of the cover shown in FIG. 2 and taken on section line 44 of the latter; and

FIG. 5 is another cross-sectional view of the nose end 4 portion of the unit of FIG. 1, similar to that of FIG. 3, but with an hypodermic needle aifixed thereto by means of a set adhesive, and a cannula cover shown in phantom frictionally mounted on the last distal taper of the nose end of the unit and completely covering said needle.

Referring to FIG. 1, the cartridge-syringe unit comprises a body 2 of polypropylene having a main cylindrical portion 3 and a narrowed extension or nose portion 4. As seen in FIG. 3, the nose portion 4 comprises a first region 5, which is adjacent main cylinder portion 3 and has a smaller diameter in relation thereto. The exterior surface 6 of the first region 5 is provided, substantially medially thereof, with an annular head 7. The distal section of said surface 6 is provided with a screw thread 8.

A second region 9, having a diameter smaller than that of said first region 5, is located distally of the latter, and has a slightly conical configuration with the gentle taper thereof extending inwardly towards its main axis in the direction distally of said first region 5. A third region 10 of the nose portion 4 is located distally of the second region 9 and has a substantially cylindrical configuration of still smaller diameter than that of the adjacent tapered end of conical second region 5. The third region 10 terminates at a substantially blunt end 11.

Defined by the wall 12 of the first region, which is of substantially the thickness of the wall 13 of the main cylindrical portion 3 and, in effect an extension thereof, is a first well 14 communicating with the interior of the main cylindrical portion 3. A second smaller well 15 extends distally of the first well 14 approximately to the medial region of the second region 9 of nose portion 4, and is in turn defined by a wall 16 which is of continuation of the walls 13 and 12 of the main cylindrical portion 3 and the first region 5, respectively, thereby to have the same thickness as said walls and hence an inwardly tapering interior surface 17 parallel to the outer surface of second region 9.

An axial bore 18 extends from the end of second well 15, with which it is in communication, and through the blunt end 11 of the terminal third region 10. Bore 18 has a first section 19 having a diameter which, preferably, is substantially equal to the internal diameter of a cannula with which the device may be used, as described hereinafter. Distally of this first section 19 of bore 18 is a second section 20 thereof, which has a diameter substantially equal to the exterior diameter of said cannula with which the device may be used. This section 20 of bore 18 extends approximately from a medial point of the second region 3 of nose portion 4 to medial point of the third region 10 of nose portion 4 where it opens out into a third section 21 having a larger diameter than said second section 20 of bore 18. The third section 21 of bore 18 opens out of blunt end 11 of the third region 10 of nose portion 4, and said section 21 is provided medially thereof with an internal annular head 22.

In one embodiment of the invention, wherein the device is not provided with an hypodermic needle permanently attached thereto, a cap 23 for nose portion 4 is provided. Cap 23 comprises an integral main substantially cylindrical wall 24 and closure Wall 25 for one end of said cylindrical wall 24. The internal surface 26 of wall 24 tapers inwardly towards the main axis of cap 23 in the direction from the open end 27 to the closed end thereof, and is contoured to permit a press fit via open end 27 thereof on the tapered second region 9 of nose portion 4 of unit 2. Cylindrical wall 24 is provided, at the periphery thereof which encircles the closure wall 25, with a bead 28 having flutings 29 therein. For decorative purposes, the outer surface of closure wall 25 is provided centrally with a depression 34.

Depending from the interior surface 30 of closure wall 25 and axially thereof is a plug 31 provided with a first proximal extension 32 having an external diameter permitting a press fit within the diameter defined by annular bead 22 in the third section 21 of bore 18 and a distal further extension 33 of lesser diameter dimensioned to fit snugly within the interior of the second section 20 of bore 18. In FIG. 3, there is illustrated the relationship of the aforesaid structures of cap 23 (shown in phantom) to the second region 9 of nose portion 4 and to the second and third sections 20 and 21, respectively, of bore 18, when the cap is frictionally mounted on nose portion 4 in sealing engagement therewith.

In FIG. 5 there is illustrated an embodiment of the invention when the universal disposable cartridge unit 2 of the invention is provided with an hypodermic needle 35 permanently affixed thereto. As appears in said FIG. 5, the blunt end 36 of needle 35 fits snugly within second bore section 20 with end 36 of needle 35 abutting the shoulder 37 formed at the junction of the first and second bore regions 19 and 20, respectively, with said first bore region 19 communicating directly with the cannula bore 38 of hypodermic needle 35. Maintaining needle 35 in the stated relationship is a plug of cured adhesive 39, which, preferably, comprises a thermoset epoxy resin.

Epoxy resins have an excellent afiinity for metal and form a permanent bond therewith regardless of the smoothness of the surface of the metal. Accordingly, these resins permanently attach to the metal hypodermic needles thereof. On the other hand, the epoxy resins do not have the same adhesive propensity or aflinity with respect to the polypropylene resins of which the unit 2 of the invention is preferably formed. However, the annular head 22 in the third section 21 of bore 18 functions to lock the plug of set epoxy resin 39 in said section 21 of bore 18 thereby maintaining the desired permanent attachment of hypodermic needle 35 to unit 2. As illustrated in phantom in FIG. 5, a removable rubber cannula cover 40, which, at its open end 41 resiliently engages over third region of nose portion 4, and for the remainder of the length 42 thereof encases hypodermic needle 35, maintains the latter in sterile condition.

The epoxy resin, which is to provide the ultimate plug of cured adhesive 39 by which needle 35 is affixed to unit 2, may be applied to maintain the assembly of the polypropylene unit 2 and the metal hypodermic needle 35, in any form, such as a liquid, powder, or a moulded solid or semi-solid. However, it is preferred to utilize a solid or semi-solid epoxy resin, which contains the latent hardening system admixed therein, and is moulded in the form of an annular pill. In one preferred mode of assembly, the needle 35 is positioned in bore sections 20 and 21 with its blunt end 36 abutting shoulder 37 at the junction of bore sections 19 and 20. The annular epoxy pill is threaded over the sharp end of the needle and advanced therealong, abuts the blunt end 11 of nose portion 4 surrounding the opening of third bore section 21. Thereafter, the epoxy resin may be brought to the gel form by heating to a temperature which, however, does not adversely affect the polypropylene material of the unit 2. The resin pill may then be subjected to a pressure force axially thereof to cause the resin to enter and fill the third bore region 21. Curing heat may then be applied locally to the epoxy resin to cause setting thereof in situ, whereby the hypodermic needle 35 is afiixed thereto and the plug of resin 39 is locked in bore section 21 by annular head 22 therein.

In the use of the unit 2, when it is not provided with a permanently affixed hypodermic needle, the cap 23, preferably provided onthe nose portion 4 thereof (FIGS. 3 and 4) to assure sterility, whether the unit 2 is factoryfilled with medicament or provided as a sterile empty, may be removed. There may then be attached to the unit a structure selected for the particular use to which the unit is intended to be put. For example, if the disposable cartridge unit is to be used for injecting a medicament hypodermically, a standard luer needle may be affixed to the unit by tightening the clamping structure of the needle on the tapered surface of the second region 9 of nose portion 4. When the unit, provided with an hypodermic needle affixed thereto, is to be used in a hypodermic syringe appliance which is normally provided, as disclosed in said US. Patent 2,671,449, for example, either with a retaining ledge or a screw thread at the aperture adapted to have inserted therethrough the nose portion of a cartridge unit; either the annular head 7 or the screw thread on the first region 5 of nose portion 4 of the unit 2 described hereinbefore may be used alternatively for retaining the unit 2 in the syringe in the desired relationship for use.

While several preferred embodiments of the universal disposable cartridge unit in accordance with the invention, and preferred methods of assemblage have been described in detail herein, as will be understood by those skilled in the art, various changes and modifications may be made therein without departing from the spirit and scope of the invention as defined in the appended claims. Merely by way of example, the choice of plastic materials for the unit body and/or for the adhesive, when one is used to attach an hypodermic needle to the body, may be varied under certain circumstances, depending upon the nature of the material to be handled by the unit and/or the intended use of the resulting assembly. Other attachments than those specifically described or referred to herein may be employed in conjunction with the universally disposable cartridge unit of the invention. Due to the configuration of the units per se of the invention, standard molding procedures known to those skilled in the art, may be employed to advantage in the mass production of said units.

I claim:

1. A universal, disposable cartridge for parenteral administration of drugs, said cartridge comprising:

a unitary, generally cylindrical hollow body of polypropylene, said hollow body having at one end thereof (a) an integral reduced axially extending nose portion having (1) a first proximal region having a first predetermined diameter adapted to fit into a cartridge holder, a screw thread on the surface of said proximal region adapted to lock said cartridge against axial movement in a cartridge holder, which said first diameter is adapted to fit, which holder is provided with a complementary female screw thread, and a peripheral bead adapted to function as alternative locking means when the cartridge holder is not provided with a female screw thread but with a shoulder, said screw thread being located distally of said head, (2) a second region distally of said first region, said second region having a second predetermined diameter less than said first diameter of said first region, said second predetermined diameter tapering gently distally and being adapted to have alternatively afiixed thereto, the mounting means of a standard luer type needle or a friction cap for said nose portion, and (3) a third region distally of said second region, said third region having a third predetermined diameter less than said second diameter and adapted to receive the end of a flexible cannula cover thereon;

said reduced nose portion also having (b) a bore extending therethrough axially thereof, and communicating at its proximal end with the interior of said hollow body, said bore having (1) a first proximal region having a first predetermined diameter less than the diameter of the hypodermic needle with which said cartridge is adapted to be used,

(2) a second region distally of said first region, said second region having a second 7 8 predetermined diameter adapted to receive the closed end thereof, whereby said cap is the blunt end of the hypodermic needle with adapted to be mounted on said body with a fricwhich said cartridge is adapted to be used, tion fit between said internal diameter of said and forming at the juncture of said second cup and said tapered diameter of said second region of said bore with said first region, a region of said nose portion, shoulder, and said cap also having (3) a third region distally of said second re- (b) a plug member integral with the interior of gion, said third region having a third prethe closed end thereof, said plug member havdetermined diameter larger than said secing 0nd diameter, said third region opening 10 (1) a proximate cylindrical portion dimenout unobstructedly at the distal end of said sioned to fit within said distal portion of nose portion and adapted to receive a charge said bore of said body as diminished by of adhesive material therein for encircling said annular bead, and the circumference of the hypodermic needle (2) a distal cylindrical portion dimensioned with which said cartridge is adapted to be to fit within said smaller portion of said used, said third region of said bore having bore. on its interior surface, an annular head as locking means for the adhesive material, References Cited which, when introduced into said third re- UNITED STATES PATENTS gion of said bore and cured does not have an atfinity for said polypropylene of which g f 2. A cartridge as claimed in claim 1 in combination 0 with a cap of polypropylene removably mounted on said FOREIGN PATENTS nose portion of said body, said cap comprising: 1,061,969 11/1955 Germany a generally Cup-Shaped body having 584,600 1/1947 Great Britain.

(a) a predetermined internal diameter substantially equal to the external diameter of said RICHARD A GAUDET Primary Examiner second region of said nose portion of said cartridge and tapering inwardly in the direction 0 BAKER, AS81510!" E from the open end of said cup-shaped body to 

